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CraNIRS Clinical Study

A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04086056
Acronym
CraNIRS
Enrollment
40
Registered
2019-09-11
Start date
2020-01-20
Completion date
2023-10-11
Last updated
2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniosynostoses

Brief summary

Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems. In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses. In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull. Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.

Interventions

Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Months
Healthy volunteers
No

Inclusion criteria

* Boys and girls. * Aged 3 to 18 months old. * Subjects with a craniosynostosis diagnosis confirmed by imaging. * Craniosynostosis requiring a corrective surgery in ventral position. * Parents/ legal guardian must provide non opposition prior to participation in the study.

Exclusion criteria

\- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.

Design outcomes

Primary

MeasureTime frameDescription
Regional cerebral oxygen saturation measureDay 0 before anesthesiaVariations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026